FDA.reportPublic FDA data

MYOBLATE

Primary DI
08809295147320
Brand
MYOBLATE
Company
RF Medical Co.,Ltd.
Model
VCTM 35XXB
Published
2023-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
JOSElectrode, Electrosurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
JOSElectrode, ElectrosurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232763000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232763000Electrode Handpieces (VCT, RFTV, BMDT series)RF Medical Co., Ltd.2023-10-04GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809295147320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809295147320088092951473208809295147320

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolarA semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) guidance] to deliver radio-frequency current in a monopolar configuration from a system generator to coagulate/ablate tissues (excluding the CNS and heart) for the treatment of tumours (e.g., in the liver); in addition to percutaneous access it might also be intended for laparoscopic and/or open surgical use. It includes one or more distal monopolar electrode(s) which may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690514869
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800142906435BIG-TIP™BT 1030OB2025-09-05
08800142906442BIG-TIP™BT 1035OB2025-09-05
08800142906459BIG-TIP™BT 1040OB2025-09-05
08800142906534BIG-TIP™BT+1505B2025-09-05
08800142906541BIG-TIP™BT+ 2005B2025-09-05
08800142906558BIG-TIP™BT+ 2010B2025-09-05
08800142906565BIG-TIP™BT+ 2015B2025-09-05
08800142906572BIG-TIP™BT+ 2505B2025-09-05
08800142906886BIG-TIP™CWT 3505B2025-09-05
08800142906893BIG-TIP™CWT 3535B2025-09-05
08800142906909BIG-TIP™CWT 3540B2025-09-05
08800142907005BIG-TIP™CWT 3505RB2025-09-05
08800142907012BIG-TIP™CWT 3535RB2025-09-05
08800142907029BIG-TIP™CWT 3540RB2025-09-05
08800142909672BIG-TIP™JET 1020B2025-09-05
08800142909689JET-TIP®JET 1025B2025-09-05
08800142909719JET-TIP®JET 1505B2025-09-05
08800142909726JET-TIP®JET 2005B2025-09-05
08800142909733JET-TIP®JET 1505QB2025-09-05
08800142909740JET-TIP®JET 1510QB2025-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848657078399AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-07-10
00848657078405AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-07-10
03665415002710Bipolar electrode UNIV / THIN, extra length (round ; Fr26)LAMIDEY NOURY MEDICALGEI2026-07-10
07613327666878N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666885N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666892N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666908N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666915N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666922N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
00190776421755MillenniumAvalign Technologies, Inc.GEI2026-06-24
00813527028590E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028613E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028637E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028651E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028675E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028699E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
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00813527028736E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
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00813527028774E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028798E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028811E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028835E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028859E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028873E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028897E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028910E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527029153E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
B112S03086NSU200STINGRAY SURGICAL PRODUCTSSTINGRAY SURGICAL PRODUCTS L.L.C.GEI2026-06-10
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09